Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Treatment | Closed | any age | EORTC-08892 |
Objectives
I. Determine whether the response rate of previously treated patients with small cell lung cancer to vinorelbine warrants further evaluation of the therapeutic efficacy in previously untreated patients. II. Delineate further the toxicity of vinorelbine.
Entry Criteria
Disease Characteristics:
See General Eligibility Criteria
Patient Characteristics:
See General Eligibility Criteria
General Eligibility Criteria:
Patients of any age with histologically or cytologically confirmed progressive recurrent small cell bronchogenic carcinoma who are not candidates for curative surgery or radiotherapy. There must be no brain involvement or leptomeningeal disease unless controlled by radiotherapy. Patients must have responded to initial chemotherapy, and treatment must have been discontinued at least 3 months prior to entry; at least 4 weeks must have elapsed since prior radiotherapy, and all toxic manifestations must have resolved. Measurable or evaluable disease is required and must reside outside areas of prior radiotherapy. Measurable disease is defined as bidimensionally measurable (e.g., metastatic pulmonary nodules, lymph nodes, and subcutaneous lesions) or unidimensionally measurable (e.g., mediastinal adenopathy, malignant hepatomegaly, or abdominal masses) by ruler or calipers. Mediastinal and hilar involvement may be measured by subtracting the mediastinal or hilar width on a preinvolvement x-ray from the width containing malignant disease, and malignant hepatomegaly is considered measurable if the liver descends 5 cm below the costal margin or xiphoid process during quiet respiration. Evaluable disease is defined as malignant disease evident on clinical examination but not measurable by ruler or calipers (e.g., pelvic and abdominal masses, lymphangitic or confluent multinodular lung metastases, skin metastases, and deviated or obstructed ureters or gastrointestinal tract). The following laboratory parameters are required: WBC greater than 4,000 and platelets greater than 100,000; bilirubin no more than 1.5 mg/dl (25.6 micromoles/liter); and creatinine no more than 1.5 mg/dl (132 micromoles/liter) and/or creatinine clearance at least 60 ml/minute. There must be no prior or concurrent second malignancies other than cone-biopsied in situ carcinoma of the cervix uteri and adequately treated basal or squamous cell carcinoma of the skin. Patients who are poor medical risks because of nonmalignant systemic disease are ineligible, as are those with active, uncontrolled infection.
Expected Enrollment
If 3, 4, or 5 or more responses are seen among the first 19 patients, then 1, 3, or 5 additional patients, respectively, will be entered.
Outline
Nonrandomized study. Single-agent Chemotherapy. 5'-nor-Anhydrovinblastine, Navelbine, Vinorelbine.
Trial Lead Organizations
European Organization for Research and Treatment of Cancer
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| Jacek Jassem, MD, PhD, Protocol chair | |
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Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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